Data is the backbone of Artificial Intelligence (AI) applications, including Medical Device Software (MDS) AI models which rely on sensitive health data. Assuring security of this sensitive health data is a key requirement for MDS AI models and there should be a structured way to manage the risk caused by data security compromises. Implementing a security risk management standard/framework is an effective way to develop a solid baseline for managing security risks, measuring the effectiveness of security controls and meeting compliance requirements. In this paper, nine risk management standards/frameworks in data/information security, AI, Medical Devices (MDs) and AI-enabled MDs domains are evaluated to identify their gaps and implementation challenges when applying them to assure data security of MDS AI models. The results show that currently there is no specific standard/framework that specifically addresses data security risk management of MDS AI models, and that existing standards/frameworks have several gaps such as complexity of the implementation process; lack of detailed threat and vulnerability catalogues; lack of a proper method for risk calculation/estimation; and lack of risk controls and control implementation details. These gaps necessitate the need for the development of a new data security risk management framework for MDS AI models.

Together with many success stories, promises such as the increase in production speed and the improvement in stakeholders’ collaboration have contributed to making agile a transformation in the software industry in which many companies want to take part. However, driven either by a natural and expected evolution or by contextual factors that challenge the adoption of agile methods as prescribed by their creator(s), software processes in practice mutate into hybrids over time. Are these still agile? In this article, we investigate the question: what makes a software development method agile? We present an empirical study grounded in a large-scale international survey that aims to identify software development methods and practices that improve or tame agility. Based on 556 data points, we analyze the perceived degree of agility in the implementation of standard project disciplines and its relation to used development methods and practices. Our findings suggest that only a small number of participants operate their projects in a purely traditional or agile manner (under 15 percent). That said, most project disciplines and most practices show a clear trend towards increasing degrees of agility. Compared to the methods used to develop software, the selection of practices has a stronger effect on the degree of agility of a given discipline. Finally, there are no methods or practices that explicitly guarantee or prevent agility. We conclude that agility cannot be defined solely at the process level. Additional factors need to be taken into account when trying to implement or improve agility in a software company. Finally, we discuss the field of software process-related research in the light of our findings and present a roadmap for future research.

This paper details the expert review of a framework developed to implement a novel testing approach called taxonomy-based testing (TBT) for the medical device software domain. This framework proposes three approaches to implement TBT and has been validated by experts from the software testing industry and the medical device software domain. This paper details the results from the expert review. The expert review focused on validating the three approaches to TBT, the benefits of TBT to medical device software development, the accuracy of mappings of testing techniques from ISTQB and ISO/IEC/IEEE 29119-4:2015 to defects from a defect taxonomy, the integration of TBT into the standard test processes, ISTQB and ISO/IEC/IEEE 29119-2:2013 and the structure of the framework. The contribution of this paper is to reveal that (i) the framework is implementable in medical device software organisations that follow the IEC 62304:2006+A1:2015 software development process or that use standard test processes, (ii) using a defect taxonomy could standardise the application of experience-based approaches to software testing and (iii) considering potential defects before writing test cases could identify additional defects for test cases.

Abstract The future will encompass heavily interconnected, distributed, heterogeneous and intelligent systems which are bound to have a significant economic and social impact. Cyber physical systems (CPS) such as autonomous cars, smart electric grid, implanted medical devices and smart manufacturing are some practical examples of these intelligent systems. However, due to the open and cooperative nature of CPS, assuring their dependability is a challenge. The DEIS project addresses this important and unsolved challenge by developing the concept of a digital dependability identity (DDI). A DDI contains all the information that uniquely describes the dependability characteristics of a CPS or CPS component. DDIs are synthesised at development time and are the basis for the (semi)automated integration of components into systems during development, as well as for the fully automated dynamic integration of systems into systems of systems in the field.

Health Information Technology Systems (HITS) are increasingly used to improve the quality of patient care while reducing costs. These systems have been developed in response to the changing models of care to an ongoing relationship between patient and care team, supported by the use of technology due to the increased instance of chronic disease. However, the use of HITS may increase the risk to patient safety and security. While standards can be used to address and manage these risks, significant communication problems exist between experts working in different departments. These departments operate in silos often leading to communication breakdowns. For example, risk management stakeholders who are not clinicians may struggle to understand, define and manage risks associated with these systems when talking to medical professionals as they do not understand medical terminology or the associated care processes. In order to overcome this communication problem, we propose the use of the “Three Amigos” approach together with the use of the SIMPLE tool that has been developed to assist patients in understanding medical terms. This paper examines how the “Three Amigos” approach and the SIMPLE tool can be used to improve estimation of severity of risk by non-clinical risk management stakeholders and provides a practical example of their use in a ten step risk management process.

Abstract Defect‐based testing is a powerful tool for finding errors in software. Many software manufacturers avoid this method because it requires a detailed defect taxonomy that is expensive to construct and difficult to validate. The Association for the Advancement of Medical Instrumentation is developing SW91, a defect taxonomy to be published as a standard for health software. This paper details three methods to validate SW91 for its comprehensiveness. The initial validations of SW91 were conducted via mapping vulnerabilities from the common weakness enumeration and a dataset from a medical device software development company in Ireland. Taxonomy‐based testing is another validation method proposed in this research, and its applicability was investigated using empirical data from a medical device software development company in Ireland. Finally, the paper details future plans to implement taxonomy‐based testing to improve software quality in medical device software and to validate SW91. This validation will focus on the efficiency, reliability, and ability to perform useful analyses and defect coverage of SW91.

Abstract Medical device software development organizations are bound by regulatory requirements and constraints to ensure that developed medical devices will not harm patients. Medical devices have to be treated as complete systems and be evaluated in this manner. Instead of manufacturers having to ensure compliance to various regulatory standards individually, the authors previously developed a medical device software process assessment framework called MDevSPICE®that integrates the regulatory requirements from all the relevant medical device software standards. The MDevSPICE®was developed in a manner that suits plan‐driven software development. To improve the usability of MDevSPICE®in agile settings, we extended the assessment approach. The hybrid assessment approach described here combines the MDevSPICE®‐based process assessment method with steps for prioritization of improvement needs through value stream mapping and enabling process improvement through the use of KATA technique. This approach integrates agile methods into the medical device software development process while adhering to the requirements of the regulatory standards. This paper describes the implementation of the approach within 4 organizations that develop software in line with medical device regulations.

Software and system development faces numerous challenges of rapidly changing markets. To address such challenges, companies and projects design and adopt specific development approaches by combining well-structured comprehensive methods and flexible agile practices. Yet, the number of methods and practices is large, and available studies argue that the actual process composition is carried out in a fairly ad-hoc manner. The present paper reports on a survey on hybrid software development approaches. We study which approaches are used in practice, how different approaches are combined, and what contextual factors influence the use and combination of hybrid software development approaches. Our results from 69 study participants show a variety of development approaches used and combined in practice. We show that most combinations follow a pattern in which a traditional process model serves as framework in which several fine-grained (agile) practices are plugged in. We further show that hybrid software development approaches are independent from the company size and external triggers. We conclude that such approaches are the results of a natural process evolution, which is mainly driven by experience, learning, and pragmatism.

Abstract Today, the growth of medical devices and mobile medical applications is increasing enormously, thanks to the efficiency and enhancement of new technology. When it comes to mobile medical apps, developers need to understand what is required when a mobile application fulfils the definition of a medical device. Such applications have to be developed in compliance with medical device regulations. This can be a challenge for mobile medical application developers, as medical device software is normally developed in a manner that will also ensure the production of regulatory documentation that is essential to market such devices. In this paper, we identify the need for a mobile medical application development framework, the key criteria for such a framework, and describe how the results were collected through performing a Medical Device Software Development workshop. Furthermore, we describe how MDevSPICE together with an agile software development approach can be tailored to support a mobile medical applications development framework. We detail one of the key criteria for mobile medical application development framework—traceability.

Software systems are becoming increasingly complex. Within safety critical domains such as medical device software, this increasing complexity is placing growing demands on manufacturers who must ensure their software not only meets functional requirements but is also safe and reliable. However, the Food and Drugs Administration who regulate medical device software in the United States report a significant increase in recalls between years 2003 and 2012 and have cited software difficulties as one of the frequent causes of recalls. Furthermore a recent analysis of traceability documentation submitted to the Administration has revealed that the traceability data was incomplete, incorrect, and conflicting in many cases. This is problematic as traceability plays an important role in the development of safe and reliable software. In this paper we present the validation, through industry trial, of a traceability assessment and implementation framework which we have developed to assist medical device organizations implement traceability in an efficient and regulatory compliant manner. Our findings show that implementation of the framework within two organizations improved their traceability process and that both organizations found the framework to be both useful and usable.

Mobile medical apps play an important role within the healthcare industry. Developers of mobile medical apps need to understand what is required when a mobile application fulfils the definition of a medical device. Such applications have to be developed in compliance with medical device regulations. This can be a challenge for mobile medical application developers as medical device software is normally developed with a focus upon producing the regulatory documentation that is essential to market such devices. Regulatory compliance is usually achieved by adopting a plan-driven software development approach, which is not typically the method used to develop mobile applications. MDevSPICE® is a medical device software process framework that integrates processes from various medical device software and generic software development best practice standards. In this paper the authors describe how the MDevSPICE® framework can be tailored to support mobile medical applications development by introducing agile practices into the framework.

A common challenge in life is to evaluate and deal with risks. Even though Risk management is fundamental to any activity, it is too often evaluated and managed from a qualitative rather than a quantitative perspective. In order to improve, too often organizations are seeking compliance against a single model/approach, forgetting that most often 'one model doesn't fit all' and that the target process model is the organizational one, strengthened by external best practices. An approach to process improvement that takes this into consideration is LEGO (Living EnGineering prOcess). LEGO extracts the most useful Elements of Interest (EoI) from several types of maturity models into an organizational Business Process Model (BPM) in order to facilitate to the achievement of higher organizational maturity and capability levels, that's the definitive intended target to be improved. This paper applies the LEGO approach to Risk Management, analyzing several Risk Management Maturity Models and unifying their practices in order to come up with a more comprehensive process model on risk management integrating multiple views.

Abstract Software development companies moving into the medical device domain often find themselves overwhelmed by the number of regulatory requirements they need to satisfy before they can market their device. Several international standards and guidance documents have been developed to help companies on their road to regulatory compliance, but working their way through the various standards is a challenge in itself. In order to help software companies in the medical device domain, we have developed an integrated framework of medical device software development best practices called MDevSPICE®. This framework integrates generic software development best practices with medical device standards' requirements enabling consistent assessment of medical device processes. MDevSPICE® can be used by software companies evaluating their readiness for regulatory audits as well as by large medical device manufacturers for selecting suitable software suppliers. In this paper, we describe the development of the MDevSPICE® framework—its process reference model, process assessment model, assessment method and assessor training and certification scheme. We also illustrate the benefits and significance of the framework for the medical device‐manufacturing community as learned from the various MDevSPICE® assessments that we conducted to date. Copyright © 2016 John Wiley & Sons, Ltd.

Abstract The use of networked medical devices can provide a number of benefits such as improved patient safety, a reduction in adverse events and reduced costs of care. Today, medical devices are increasingly designed for incorporation into a hospital's general IT network, which allows devices to exchange critical information. However, connecting devices in this way can introduce risks potentially negating the benefits to patients. While the IEC 80001‐1 standard has been developed to aid Healthcare Delivery Organisations (HDOs) in addressing these risks, HDOs often struggle to understand and implement the requirements. The MedITNet framework has been developed to allow HDOs to assess the capability of their risk management processes against the requirements of IEC 80001‐1. MedITNet provides a flexible assessment framework enabling HDOs to gain a greater understanding of the requirements of the standard and to improve risk management processes by determining their current state and highlighting areas for improvement. This paper examines the challenges faced by HDOs in the risk management of medical IT networks and briefly explains the components of the MedITNet framework and how the framework addresses these challenges. The use of Action Design Research (ADR) in the development and validation of MedITNet is also discussed focusing on a pilot implementation of the assessment method and expert review of the overall framework. The changes to the framework and its components as a result of the validation process are also discussed. Copyright © 2016 John Wiley & Sons, Ltd.

Abstract Organizations engaged in medical device software development are required to demonstrate compliance with a set of medical device standards and regulations before the device can be marketed. One such standard IEC 62304, Medical Device Software—Software Life Cycle Processes, defines the processes that are required in order to develop safe software. Demonstrating compliance with IEC 62304 can be problematic for organizations that are new to or have limited experience in the domain. The standard defines what processes must be carried out but does not state how. In a review of a number of such organizations, it was found that the development of a software development plan proved to be a difficult task. In this work we have created a software development plan template to assist organizations with this arduous task. The software development plan template will be validated with these organizations as part of the future work.

Software development companies moving into the medical device domain often find themselves overwhelmed by the number of regulatory requirements they need to satisfy before they can market their device. Several international standards and guidance documents have been developed to help companies on their road to regulatory compliance but working their way through the various standards is a challenge in itself. In order to help software companies in the medical device domain, we have developed an integrated framework of medical device software development best practices called MDevSPICE®. This framework integrates generic software development best practices with medical device standards’ requirements enabling consistent and thorough assessment of medical device processes. MDevSPICE® can be used by software companies evaluating their readiness for regulatory audits as well as by large medical device manufacturers for selecting suitable software suppliers. The MDevSPICE® framework consists of a process reference model, a process assessment model, an assessment method, and training and certification schemes. The framework has been validated using expert reviews and through MDevSPICE® assessments in industry. In this paper, we describe the MDevSPICE® process assessment framework focusing on its benefits and significance for the medical device manufacturing community as learned from MDevSPICE® assessments conducted to date.

The use of networked medical devices can provide a number of benefits such as improved patient safety, reduced costs of care and a reduction in adverse events. Traditionally, medical devices were placed onto a proprietary IT network provided by the manufacturer of the device. Today, medical devices are increasingly designed for incorporation into a hospital’s general IT network enabling devices to exchange critical information. However, this can introduce risks and negate the potential benefits to patients. While the IEC 80001-1 standard has been developed to aid Healthcare Delivery Organisations (HDOs) in addressing these risks, HDOs may struggle to understand and implement the requirements. The MedITNet framework has been developed to allow HDOs to assess the capability of their risk management processes against the requirements of IEC 80001-1. MedITNet provides a flexible assessment framework enabling HDOs to gain a greater understanding of the requirements of the standard and to improve risk management processes by determining their current state and highlighting areas for improvement. This paper examines the challenges faced by HDOs in the risk management of medical IT networks and briefly explains the components of the MedITNet framework and how the framework addresses these challenges. This paper also details how Action Design Research (ADR) was used in the development and validation of MedITNet.

Medical device standards outline the requirements for developing medical devices. These standards, however, do not outline how these requirements should be implemented causing difficulties for organisations entering the medical device domain. The goal of this study is to validate a roadmap for the implementation of the ISO 14971 standard. The validation examined the arrangement of the milestones within the roadmap and grouping of the goals into milestones. Five experienced risk management personnel in the medical device domain were asked to complete an online questionnaire examining their opinion on the structure and content of the roadmap. Overall participants found the roadmap, in general, to be well structured and well organised and made some recommendations for improving the roadmap through merging of specific goals and rearrangement of the milestones within the roadmap. Copyright © 2015 John Wiley & Sons, Ltd.

Abstract Software that is incorporated into a medical device, or which is a standalone medical device in its own right, is of a safety critical nature and subject to regulation from various jurisdictions. In order to satisfy jurisdictional regulations, developers of medical device software adopt standards and guidance provided by international standards bodies and regulators. However, the various standards and guidance documents are often not developed as a single cohesive set resulting in a complex and costly challenge for medical device software developers when complying with regulation. The aim of this paper is to describe the integration of medical device guidance documents and software engineering standards into a unified framework for medical device software process assessment called MDevSPICE®. The paper illustrates the development of both the process reference model and the process assessment model (PAM) of MDevSPICE®. The MDevSPICE® PAM can help software developers to prepare for the regulatory audits, which they must satisfy as a prerequisite to placing their products on the market. The MDevSPICE® PAM can also assist medical device manufacturers to select competent software suppliers. Copyright © 2015 John Wiley & Sons, Ltd.

Abstract Most existing software systems that lack explicit traceability links between artefacts, or if implemented, are often not leveraged to take advantage of the information it can provide to a development or validation team. Within the medical device domain, as in other safety critical domains, regulation normally requires such systems that are certified before entering service. This involves submission of a safety case (a reasoned argument that the system is acceptably safe) to the regulator. A safety case should include evidence that the organisation has established effective software development processes. At the heart of such processes, they must incorporate traceability. However, numerous barriers such as a lack of awareness of traceability and a lack of guidance as to how to implement traceability hamper its effective implementation. In this paper, we address the lack of guidance on traceability implementation by presenting our experience of developing and trialling a traceability assessment model in two medical device organisations. We show that the assessment model was successful in identifying strengths and weaknesses in both organisations' implementation of traceability. Through experience of trialling the model, we propose an idea to improve it by automation, using the Open Services for Lifecycle Collaboration initiative. Copyright © 2015 John Wiley & Sons, Ltd.

SUMMARY Non‐safety critical software developers have been reaping the benefits of adopting agile practices for a number of years. However, developers of safety critical software often have concerns about adopting agile practices. Through performing a literature review, this research has identified the perceived barriers to following agile practices when developing medical device software. A questionnaire‐based survey was also conducted with medical device software developers in Ireland to determine the barriers to adopting agile practices. The survey revealed that half of the respondents develop software in accordance with a plan‐driven software development lifecycle and that they believe that there are a number of perceived barriers to adopting agile practices when developing regulatory compliant software such as being contradictory to regulatory requirements, insufficient coverage of risk management activities and the lack of up‐front planning. In addition, a comparison is performed between the perceived and actual barriers. Based upon the findings of the literature review and survey, it emerged that no external barriers exist to adopting agile practices when developing medical device software and the barriers that do exists are internal barriers such as getting stakeholder buy in. Copyright © 2013 John Wiley & Sons, Ltd.

The incorporation of a medical device into an IT network can introduce risks that may not have been addressed during the design and manufacture of the device. IEC 80001-1 is a lifecycle risk management standard which was developed to address these risks. This paper presents research which has been performed to date which has led to the development of a Process Reference Model (PRM) and Process Assessment Model (PAM) which can be used by Healthcare Delivery Organisations to assess themselves against IEC 80001-1. This paper also presents future work in this area which includes the development of an assessment method for IEC 80001-1 and the validation of the PRM, PAM and assessment method.

SUMMARY Traceability is central to medical device software development and essential for regulatory approval. For compliance to be achieved, an effective traceability process needs to be in place. This process must ensure the need for clear linkages and traceability from software requirements – including risks – through the different stages of the software development and maintenance lifecycles. This is difficult to achieve because of the lack of specific guidance within the medical device standards and documentation. This has resulted in many medical device companies employing inefficient software traceability processes. In this paper, we outline the development and implementation of Med‐Trace, a lightweight software traceability process assessment and improvement method developed specifically for the medical device industry. We also present and discuss findings from two industry‐based Med‐Trace assessments. Copyright © 2011 John Wiley & Sons, Ltd.

The demand for medical device software continues to grow and there is an associated increase in its importance and complexity.This paper discusses medical device software process assessment and improvement.It outlines Medi SPICE, a software process assessment and improvement model which is being developed to meet the specific safety-critical and regulatory requirements of the medical device domain.It also details the development of a subset of the Medi SPICE process reference model for inclusion in the next release of the IEC 62304 standard: Medical device software -Software life cycle processes.IEC 62304 is a key standard for medical device software development and is approved by many national regulatory bodies including the Food and Drug Administration in the United States and the European Union.This paper also outlines 3 lightweight software process assessment methods which have been developed in tandem with Medi SPICE.Finally the timeline for the release of the full Medi SPICE model is provided.

SUMMARY Software product lines (SPL) and Agile practices have emerged as new paradigms for developing software. Both approaches share common goals; such as improving productivity, reducing time to market, decreasing development costs and increasing customer satisfaction. These common goals provide the motivation for this research. We believe that integrating Agile practices into SPL can bring a balance between agility and formalism. However, there has been a little research on such integration. We have been researching the potential of integrating Agile approaches in one of the key SPL process areas, product derivation (PD). In this paper, we present an outline of our Agile process model for PD that was developed through industry‐based case study research. Copyright © 2010 John Wiley & Sons, Ltd.

Abstract This article outlines the development of a software process assessment and improvement model (Medi SPICE) for the medical device industry. The article details how medical device regulations may be satisfied by extending relevant processes and practices from ISO/IEC 15504‐5. The article also describes the proposed phases of delivery for Medi SPICE. Medi SPICE will define a process reference model, process assessment model (PAM) and organizational maturity model (OMM). The Medi SPICE PAM will be used to perform ISO/IEC 15504 conformant assessments of the software process capability of medical device suppliers in accordance with the requirements of ISO/IEC 15504‐2: 2003. The Medi SPICE Process Assessment Model will be based on ISO/IEC 15504‐5: 2006 and shall be extended to provide coverage of additional software development practices that are required to achieve regulatory compliance within the medical device industry. The processes will be defined within an OMM conformant with ISO/IEC TR 15504‐7:2008. Copyright © 2009 John Wiley & Sons, Ltd.

The need for software is increasingly growing in the automotive industry. Software development projects are, however, often troubled by time and budget overruns, resulting in systems that do not fulfill customer requirements. Both research and industry lack strategies to combine reducing the long software development lifecycles (as required by time-to-market demands) with increasing the quality of the software developed. Software process improvement (SPI) provides the first step in the move towards software quality, and assessments are a vital part of this process. Unfortunately, software process assessments are often expensive and time consuming. Additionally, they often provide companies with a long list of issues without providing realistic suggestions. The goal of this paper is to describe a new low-overhead assessment method that has been designed specifically for small-to-medium-sized (SMEs) organisations wishing to be automotive software suppliers. This assessment method integrates the structured-ness of the plan-driven SPI models of Capability Maturity Model Integration (CMMI) and Automotive SPICE with the flexibleness of agile practices.